Travel Vaccine Breaking News

On February 5, 2023, @Senasa_Peru tweeted that three dead sea lions and one dolphin had tested positive for the highly pathogenic avian influenza (HAPI) H5N1 virus. 

By November 30, 2022, HAPI had been reported in Ecuador and Peru related to about 14,000 pelican fatalities.

These reports indicate the ongoing HAPI outbreak has impacted numerous mammals throughout North and South America over the past year.

The USDA's Animal and Plant Health Inspection Service listing in 2023 includes about 110 H5N1 detections in skunks, bears, raccoons, and foxes confirmed in 2022.

USDA stated the Eurasian H5N1 strain initially appeared in North America in January 2022 and has affected 47 states, leading to the loss of over 58.2 million birds as of February 4, 2023.

As of February 2023, global surveillance data does not suggest widespread mammalian adaptation of the HAPI virus (low to moderate confidence), says the U.S. Centers for Disease Control and Prevention (CDC).

However, seven human infections in 2022 were related to the HAPI.

Should a HAPI crossover outbreak occur in people, the CDC says one approved bird flu vaccine is available in the U.S., but with distribution controlled by the government.

The Audenz™ monovalent, adjuvanted, cell-based inactivated influenza (H5N1) subunit vaccine was approved in 2020 to protect individuals six months of age and older in the event of bird flu pandemics.

Other bird flu vaccine candidates and monoclonal antibody treatments were funded in 2022 and are in development.

Qurient Co. Ltd. and TB Alliance recently announced that they have entered into a license agreement to develop and commercialize telacebec (Q203), a first-in-class orally available cytochrome bc1 inhibitor for treating tuberculosis (TB) and other non-tuberculosis mycobacterium infections.

The potent efficacy of telacebec against drug-sensitive and drug-resistant TB has been demonstrated in preclinical and clinical studies.

Telacebec was successfully tested in Phase 2a early bactericidal activity study for TB, and the results were published in the New England Journal of Medicine (March 2020).

Telacebec has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA.

Mel Spigelman, MD, President and CEO of TB Alliance, stated in a press release on February 3, 2023, "TB Alliance is excited to partner with Qurient to bring about the next generation of TB cures."

"New drugs like telacebec are urgently needed in the fight against TB as well as certain NTM infections – compounds with potentially impactful novel mechanisms of action can have a significant benefit in combating the TB pandemic. "

"If we expect to regain ground lost to COVID-19, we need to use every tool we have to give patients the best possible treatment and save lives."

"We look forward to advancing this new compound as part of combination regimens that could yield a short, simple, safe, and highly effective cure for all forms of TB."

Vaccines to prevent TB, such as the BCG vaccine, have been available for about 100 years and are generally available in most countries in 2023.

The Columbus City Health Department tweeted today that the current measles outbreak in central Ohio reached 42 days or two incubation periods since the last rash onset in a confirmed case.

This milestone fits the U.S. CDC's definition of the end of an outbreak; however, 'we still have test results pending for suspected cases.'

Measles outbreaks are declared when the number of cases reported in an area is higher than the expected number of cases.

Around 90% of people who are not protected will become infected following exposure to the measles virus. 

As of February 3, 2023, the City of Columbus, Ohio, reported 85 measles cases since the initial cases were reportedpotentially connectedthese most unvaccinated children had been hospitalized.

Throughout the U.S., the CDC has reported two measles cases in 2 jurisdictions in 2023.

One of these new measles cases was reported in Kentucky, with a potential connection to the Ohio outbreak.

In response, the Jefferson County Public Schools, located near Lousiville, Kentucky, began conducting measles vaccination clinics at schools for about 10,000 under-vaccinated students.

The CDC reported on January 13, 2023, nationally, the 2-dose MMR coverage was 93.5% during the 2020–2021 school year.

Measles vaccines are generally available at clinics and pharmacies in the U.S.

The Canadian government recently confirmed visitors to Buenos Aires, Argentina, should exercise high caution due to civil unrest. 

As of January 31, 2023, Canada stated when in the Buenos Aires tourist areas of La Boca, Congreso, Florida Street, the Retiro bus station area, and San Telmo, be aware of your surroundings.

And in La Boca, always remain on Caminito Street, as thefts often occur on neighboring streets, and avoid the area after dark.

Furthermore, since 2019, several incidents of tourists have been followed from Buenos Aires' Ministro Pistarini International Airport to their hotels and robbed. In some cases, the criminals responded violently when the victims resisted.

If you are the victim of a crime, call the local police at 911, as the U.S. Embassy cannot take custody of U.S. citizens or intervene in Argentine legal procedures. All U.S. citizens are subject to the laws of the Government of Argentina.

The Embassy suggests enrolling in the STEP program to receive important information about safety conditions, helping you make informed travel plans.

The U.S. Embassy in Buenos Aires is located at Av. Colombia 4300 (C1425GMN). Telephone: (54-11) 5777-4533. 

From a health perspective, the U.S. Centers for Disease Control and Prevention (CDC) says there are no travel health notices in effect for Argentina as of February 5, 2023.

However, the CDC suggests various travel vaccinations, including yellow fever.

Yellow fever vaccination with either Stamaril or YF-Vax is recommended for travelers ≥9 months of age going to Corrientes and Misiones Provinces. And is not recommended for travelers going to Formosa Province and designated areas of Chaco, Jujuy, and Salta Provinces.

And the U.K.'s travel advisory for Argentina includes notices regarding dengue and Zika virus transmission.

The U.S. Food and Drug Administration (FDA) issued an updated Emergency Use Authorization (EUA) stating that the oral antiviral Paxlovid™ is now offered to people with a SARS-CoV-2 coronavirus infection without a confirmatory test.

On February 1, 2023, Patrizia Cavazzoni, M.D. Director Center for Drug Evaluation and Research with the FDA published EAU #105, confirming certain adults and pediatric patients can be prescribed Paxlovid without completing a diagnostic test.

However, there are known drug interactions that should be reviewed.

Pfizer previously confirmed Paxlovid is contraindicated in patients with a history of clinically significant hypersensitivity reactions to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product and with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions. 

Therefore, before prescribing Paxlovid, clinicians should carefully review the patient's concomitant medications, including over-the-counter medicines, herbal supplements, and recreational drugs, says the U.S. NIH.

Pfizer Inc., Paxlovid's producer, stated on January 31, 2023, it expects a 58% reduction in related revenues in 2023.

The World Health Organization (WHO) recently reaffirmed the spreading of poliovirus, and recent polio cases remain a public health emergency of international concern (PHEIC).

The WHO's Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine-derived polioviruses (cVDPV) in the context of the global target of eradicating WPV and cessation of outbreaks of cVDPV2 by the end of 2023.  

Technical updates were received about the situation in the following countries: Afghanistan, Botswana, Canada, the Democratic Republic of the Congo, Indonesia, Madagascar, Nigeria, Pakistan, Sudan, and Zambia.

Although encouraged by the reported progress, the Committee unanimously agreed that the risk of the international spread of poliovirus remains a PHEIC and recommended the extension of Temporary Recommendations for a further three months into mid-2023.

The WHO Director-General endorsed the Committee's recommendations on February 1, 2023.

In the U.S., the Centers for Disease Control and Prevention (CDC) is leading the wastewater review for the continued spreading of poliovirus in New York, Michigan, and Pennsylvania in 2023.

The CDC stated in a Level 2 Travel Advisory posted on January 3, 2023, before traveling to any polio-risk destination, adults who previously completed the entire routine polio vaccine series receive a single, lifetime booster dose of polio vaccine.

Polio is a vaccine-preventable disease, says the CDC.

As a result, most clinics and pharmacies in the U.S. offer polio vaccination services in 2023.

A leading online pharmaceutical discount company recently responded to a first-of-its-kind disciplinary civil action by the U.S. Federal Trade Commission (FTC).

The FTC alleged GoodRx was unauthorized when it shared health information with Meta Platforms Inc.'s Facebook and Alphabet Inc.'s Google, as well as other digital firms.

The FTC issued a $1.5 million fine as an enforcement action.

The FTC issued a policy statement in September 2021 warning health apps and others that collect or use consumers' health information that they must comply with the Health Breach Notification Rule.

"Digital health companies and mobile apps should not cash in on consumers' extremely sensitive and personally identifiable health information," said Samuel Levine, Director of the FTC's Bureau of Consumer Protection, in a press release.

"The FTC is serving notice that it will use all of its legal authority to protect American consumers' sensitive data from misuse and illegal exploitation." 

On February 1, 2023, GoodRx published the following response:

'GoodRx, protecting our users' privacy is one of our most important priorities. Therefore, we are thoughtful and disciplined about what information we gather and how and why we use it.

The settlement with the FTC focuses on an old issue that was proactively addressed almost three years ago before the FTC inquiry began.

We do not agree with the FTC's allegations and admit no wrongdoing. However, entering into the settlement allows us to avoid the time and expense of protracted litigation.

We believe the requirements detailed in the settlement will have no material impact on our business or our current or future operations.

In fact, almost three years ago, before the FTC reached out to us, we proactively made updates consistent with our commitment to being at the forefront of safeguarding users' privacy.

While we used vendor technologies to advertise in a way that we believe was compliant with all applicable regulations and that remains a common practice among many health, consumer, and government websites, we are proud that we took action to be an industry leader in privacy practices.

We are glad to put this matter behind us so we can continue focusing on being a trusted source for Americans to find affordable and convenient healthcare.

The complete unedited response is available at this link.

More information on compliance and reporting breaches under the Health Breach Notification Rule are available on the FTC's Health Privacy page.

Disclosures: Precision Vax LLC participated in GoodRx programs until 2019 when it discontinued all business relationships.